[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653237":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":23,"armGroups":33,"interventions":44,"overallOfficials":48,"centralContacts":52,"locations":57,"responsibleParty":67,"collaborators":23,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":95,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Kırklareli University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Social demographic form","This form includes questions regarding women's sociodemographic characteristics, menstrual cycles, the presence of chronic diseases, menstrual symptoms, gynecological conditions, whether they have received prior education about menstruation, and whether they use pharmacological or non-pharmacological methods to alleviate premenstrual syndrome.","between 2 to 4 weeks",{"measure":14,"description":15,"timeFrame":16},"Premenstrual Syndrome Scale","Premenstrual Syndrome Scale (PMSS) is a 44-item, five-point Likert scale used to assess the severity of physical, emotional, and behavioral symptoms experienced before menstruation. Total scores range from 44 to 220, with higher scores indicating greater PMS symptom severity. A score above 50% of the maximum possible score (≥110) is considered indicative of PMS.","between 2 to 12 weeks",{"measure":18,"description":19,"timeFrame":16},"State-Trait Scale (STAI-1, STAI-2)","State-Trait Anxiety Inventory (STAI) is used to assess individuals' state anxiety (temporary anxiety) and trait anxiety (general tendency toward anxiety). It consists of two 20-item subscales, each scored on a four-point Likert scale. Total scores for each subscale range from 20 to 80, with higher scores indicating higher anxiety levels.",{"measure":21,"description":22,"timeFrame":16},"Pittsburgh Sleep Quality Index (PSQI)","Pittsburgh Sleep Quality Index (PSQI) is a self-report instrument used to assess sleep quality and sleep disturbances over the previous month. It consists of 19 items covering seven components of sleep quality. Each component is scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score of ≥5 indicates poor sleep quality.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"PARTICIPANT","Premenstrual syndrome (PMS) is a common condition among women of reproductive age, characterized by physical, psychological, and behavioral symptoms that may negatively affect quality of life, social and occupational functioning, sleep, and psychological well-being. Previous studies have demonstrated that PMS is associated with reduced sleep quality and increased anxiety. Non-pharmacological approaches, including art-based interventions, have recently gained attention as supportive strategies for managing PMS-related symptoms. Mandala coloring is a simple, accessible, and low-cost activity that does not require specific artistic skills and has been associated with reduced anxiety, stress, and psychological distress in previous studies.\n\nAlthough previous research has examined the relationship between PMS, sleep quality, and anxiety, and other studies have investigated the potential benefits of art-based interventions, there is limited evidence regarding the direct effects of mandala coloring on sleep quality and anxiety among women with PMS. Therefore, this clinical trial aims to evaluate the effect of a structured mandala coloring intervention on sleep quality and anxiety levels in women experiencing PMS. The findings may provide evidence for a simple, accessible, and non-pharmacological approach that could support the management of PMS and contribute to women's health care.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Mandala coloring group","EXPERIMENTAL","Participants in the intervention group will perform mandala coloring twice weekly for 20-30 minutes per session during the luteal phase of each menstrual cycle for three consecutive menstrual cycles. The intervention will begin approximately 14 days before the expected onset of menstruation and will be performed at a time of day chosen by the participant. Mandala templates and colored pencils will be provided by the researcher.\n\nParticipants will send a brief message to the researcher before each session and share a photograph of the completed mandala afterward. Reminder messages will be sent twice weekly to support adherence. All of the three-cycle intervention period, participants will complete the Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), and State-Trait Anxiety Inventory (STAI) through an online questionnaire, requiring approximately 30-40 minutes.",[39],"Other: Mandala coloring group",{"label":41,"type":42,"description":43,"interventionNames":23},"Control group","NO_INTERVENTION","Participants in the control group will not receive any mandala coloring intervention and will be asked to maintain their usual routines without initiating any pharmacological or non-pharmacological intervention aimed at reducing PMS symptoms. Their use of any PMS-related interventions will be monitored twice weekly by telephone throughout the three menstrual cycles. Participants in either group who initiate a pharmacological or non-pharmacological intervention for PMS symptoms during the study will be excluded.\n\nAll of the of the three-cycle study period, participants will complete the Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), and State-Trait Anxiety Inventory (STAI) through an online questionnaire, requiring approximately 30-40 minutes. After completion of the study, participants will be informed about the mandala coloring intervention and those interested will be offered the opportunity to participate individually.",[45],{"type":6,"name":35,"description":46,"armGroupLabels":47,"otherNames":23},"A mandala coloring intervention will be administered to individuals with PMS to evaluate its effects on anxiety reduction and sleep quality improvement.",[35],[49],{"name":50,"affiliation":5,"role":51},"AYCA KIRCA, Phd","STUDY_CHAIR",[53],{"name":50,"role":54,"phone":55,"phoneExt":23,"email":56},"CONTACT","05392684185","aycasolt@hotmail.com",[58],{"facility":5,"status":23,"city":59,"state":23,"zip":23,"country":60,"countryCode":23,"cosmosGeoPoint":61,"geoPoint":66,"contacts":23},"Kırklareli","Turkey (Türkiye)",{"type":62,"coordinates":63},"Point",[64,65],27.22521,41.73508,{"lat":65,"lon":64},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Ayca Solt Kirca","Asssociate professor","100653237","the-effect-of-mandala-coloring-sleep-quality-anxiety-with-premenstrual-syndrome-100653237",false,"NCT07785622","The Effect of Mandala Coloring, Sleep Quality, Anxiety With Premenstrual Syndrome","The Effect of Mandala Coloring on Sleep Quality and Anxiety Levels in Students With Premenstrual Syndrome","Inclusion Criteria:\n\n* Female students aged 18 and older\n* Scoring 45 or higher on the Premenstrual Syndrome Scale\n* Scoring 36 or higher on the State-Trait Anxiety Inventory (STAI)\n* Scoring 5 or higher on the Pittsburgh Sleep Quality Index (PSQI)\n* Having a regular menstrual cycle (21-35 days)\n* Volunteering to participate in the study\n* Fully completing the survey and scale forms\n\nExclusion Criteria:\n\n* Not wishing to continue participating in the study\n* Having any condition that hinders communication (such as impairments in hearing, speech, or comprehension)\n* Having a gynecological condition (e.g., abnormal uterine bleeding, uterine fibroids, ovarian cysts, undergoing hormonal therapy)\n* Having a chronic or physical illness\n* Having a psychological disorder\n* Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)\n* Using pharmacological or non-pharmacological methods to alleviate premenstrual symptoms (e.g., oral contraceptives, acupressure, homeopathy, yoga)\n* Having a sleep-related issue and receiving treatment for it\n* Individuals who exercise regularly",true,"FEMALE","18 Years","25 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","Premenstrual syndrome (PMS) is a common condition among women of reproductive age and is characterized by a range of physical, psychological, and behavioral symptoms that may negatively affect daily functioning, social relationships, academic and occupational life, and psychological well-being. Anxiety and sleep disturbances are among the commonly reported problems associated with PMS. Mandala coloring, as an accessible and easy-to-use art-based activity that does not require specific skills, may promote psychological relaxation, reduce anxiety, and improve sleep quality. However, the effects of mandala coloring on sleep quality and anxiety among women experiencing PMS have not been directly investigated. Therefore, this clinical trial aims to evaluate the effect of a mandala coloring intervention on sleep quality and anxiety levels in women with PMS. The findings may provide evidence for the use of mandala coloring as a simple, accessible, and non-pharmacological approach to support the management of PMS-related symptoms.",[90],"Premenstrual Syndrome",[92,93,94],"Mandala coloring","Anxiety","Sleep Disorder","NOT_YET_RECRUITING","2026-08-21",{"date":98,"type":99},"2026-08-25","ACTUAL",{"date":101,"type":84},"2026-11-01",{"date":103,"type":84},"2027-06-30",{"name":5,"class":6},1]